The Total Health Study

Overview

This study is a randomized, controlled, multiple risk intervention pilot study evaluated with clients recruited from VA Medical Center Substance Abuse Programs. The intervention combines an innovative online system with interpersonal MI-based coaching delivered in 4 sessions over 12-months time.

Full Title of Study: “Extended Care Treatment of Multiple Risk Behaviors in Complex Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: June 2, 2015

Interventions

  • Behavioral: Extended Staging Health Risk Intervention (S-HRI)
    • The S-HRI provides feedback on participants’ stages of change for each risk and the single most important step they can take to begin progressing. A counselor will review the report with participants and provide motivational interviewing (MI) coaching and referrals to relevant behavior change services. Repeated computer and individual counseling contacts at baseline, 3, 6 and 12 months follow-up are designed to support participants through the process of changing multiple risk behaviors.
  • Behavioral: Usual Care
    • Participants in the usual care condition will complete the core assessments and the S-HRA online at baseline, 3, 6, 12,and 18 months follow-up but will not meet with the study MI coach and will NOT receive any feedback or printed report until the 18-month follow-up.

Arms, Groups and Cohorts

  • Experimental: Extended Staging Health Risk Intervention (S-HRI)
    • The S-HRI provides feedback on participants’ stages of change for each risk and the single most important step they can take to begin progressing. A counselor will review the report with participants and provide motivational interviewing (MI) coaching and referrals to relevant behavior change services. Repeated computer and individual counseling contacts at baseline, 3, 6 and 12 months follow-up are designed to support participants through the process of changing multiple risk behaviors.
  • Other: Usual Care
    • Participants in the usual care condition will complete the core assessments and the Staging Health Risk Assessment (S-HRA) online at baseline, 3, 6, 12, and 18 months follow-up but will not meet with the study MI coach and will NOT receive any feedback or printed report until the 18-month follow-up.

Clinical Trial Outcome Measures

Primary Measures

  • Client engagement with behavior change service referrals
    • Time Frame: Up to18 months follow-up.

Secondary Measures

  • Behavioral changes in multiple risks
    • Time Frame: up to 18 months follow-up.
  • Improvements in health-related quality of life at 3, 6, 12, and 18 months follow-up.
    • Time Frame: up to 18 months follow-up.

Participating in This Clinical Trial

Inclusion Criteria

Inclusion criteria are: at least 18 years of age, enrolled in the San Francisco Veteran Affairs Medical Center (SF VAMC) Substance Abuse Programs, residing in the San Francisco Bay Area and not planning to relocate out of the area in the next 18 months. For patients in the Day Hospital, we will wait until they have completed one week of treatment before approaching for study involvement, as the first week is the most intensive for services. Exclusion Criteria:

Exclusion criteria are: unstable psychiatric disorder and severe cognitive impairment.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of California, San Francisco
  • Collaborator
    • National Institute on Drug Abuse (NIDA)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Judith J Prochaska, PhD, MPH, Principal Investigator, Stanford University

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